Fecal and urinary incontinence are major public health problems that disproportionately affect women and the elderly. Fecal incontinence affects 2.2% of community dwelling adults and is present in 45% of nursing home residents, while urinary incontinence severe enough to interfere with quality of life affects an estimated 6% of American adults. Together, fecal and urinary incontinence account for an estimated $26 billion in health care costs. Behavioral, medical (drug), and surgical approaches have been described for the treatment of both fecal and urinary incontinence, but the majority of patients are managed palliatively with diapers and pads. This is due in part to the fact that very few randomized, controlled trials have been done to evaluate the efficacy of these treatments and to determine which patients are most likely to benefit from them. As a consequence, insurers are reluctant to reimburse for the treatment of incontinence, and many clinicians remain skeptical. However, clinical trial methodology has evolved to the point that pivotal studies can now be done. In preparation for such trials, we propose to hold a conference to (1) bring together established researchers to exchange information on research design, (2) define research priorities from the perspective of all the professional subspecialties involved in the treatment of incontinence, (3) publish the proceedings of the conference as state of the art guidelines for conducting clinical trials in this area, and (4) request NIH to issue a Request for Applications to fund such trials. The conference will be organized by the International Foundation for Functional Gastrointestinal Disorders with the guidance of a steering committee of gastroenterologists, urologists, surgeons, gynecologists, gerontologists, psychologists, nurses, patient advocates, and NIH program staff. The conference is scheduled to take place November 3-5, 2002, in Milwaukee, and half of the invitees have accepted invitations to speak.